European Medicines Agency (EMA) has developed this training programme to support sponsor user preparedness with regard to the new way of submitting Clinical Trial Applications (CTA) in the EEA via the new Clinical Trial Information System.
A hands-on approach is taken on explaining and demonstrating the functionalities of the system, such as user management, how to submit an initial application as well as modifications, both substantial and non-substantial. Also, how to manage the life cycle of a Clinical Trial, how to apply Deferral rules and respond to a Request for Information (RFI) will be addressed.
Furthermore, search and download options will be demonstrated and how CTIS interacts with other EMA systems such as the XEVMPD, EMA account management and OMS. The training programme also includes information on how to submit Annual Safety Reports (ASRs) as well as Clinical Study Reports (CSRs).
A blended learning approach is being used, offering components on-demand, selfpaced and live virtual.
For users who plan to train others in their organisation, a separate module on training design and delivery can be added. Please register via the registration form if you are interested in attending this extra module.
Section III - Basic in training design and delivery dates are 23-24 February and 17-18 May 2022.